We help public health authorities make informed decisions

When it comes to immunization programs, there is much at stake. Successful programs improve the health of populations around the world. Unsuccessful ones can cause injury and death to many. Public health decision makers are responsible to steer immunization programs toward success. They have many critical  decisions to make with a miniscule margin of error.

They are often required to make these decisions based on available data, which may not be as reliable and timely as they need. This is due to limitations in the current research infrastructure and methodologies and the lack of resources to overcome them.

This article describes how we leverage international collaboration and emerging technology to create updated infrastructure and innovative research methods with the aim of providing decision makers with high quality and timely information in a sustainable, cost-effective manner.

Vaccine safety information: As reliable as it gets

We are raising the bar on reliable vaccine safety information
through improved accuracy and precision.

Accuracy - Result of rigorous methods
How a study is designed is the most critical determinant of the accuracy of that study's results. Study designs vary considerably and many of them do not yield findings accurate enough to be relied upon. This speaks to the challenge of respecting the epidemiologic nuances and intricacies of vaccine safety research.

At the Brighton Collaboration, we have established a global network of qualified experts with the aim of providing high quality vaccine safety information. We create methodological standards for accurate risk assessment. This includes standardized case definitions of adverse events following immunizations (AEFI), guidelines for collection, analysis and presentation of vaccine safety data, and template protocols for study design.

Through continued development of these research tools, we provide investigators with an up-to-date reference for their use. Our aim is that studies conducted using these reference tools will give public health decision makers the most accurate results available.

Precision – Result of reproducibility and large data
While methodologically sound studies may produce accurate results, such results may still have a wide standard error or confidence interval. This has the potential to compromise the reliability of results for public health decision-making. The level of precision depends largely on a study’s reproducibility and size. Each aspect presents unique challenges.

The question of reproducibility: Different investigators tend to assess the same health event differently, yielding inconsistent assessments. Studies tend to vary in methodology, making it challenging if not impossible to compare results. As a consequence, it is hard to assess whether or not differences between study results are due to methodological variability or reflect true differences.

At the Brighton Collaboration, we aim to bring clarity to this process by disseminating and implementing our standards in collaborative studies. Our aim is to harmonize vaccine safety research and thus provide decision makers with more comparable, reliable and useful findings.

Harmonization is particularly important when investigating serious AEFI, which tend to be rare. However, harmonization alone will not yield the precision required for decision making regarding rare events. To detect rare events, study sizes often need to exceed the size of individual countries. Many obstacles have rendered the linking of data across borders impossible until recently.

At the Brighton Collaboration, we are pioneering collaborative vaccine safety studies across borders. We have assessed the background incidence rates of several health events in 10 European countries based on 250 Million person-years. We have conducted a study investigating the risk of Guillain-Barré Syndrome related to pandemic Influenza (H1N1) vaccine including a population of over 120 Million people from 9 countries. These studies have yielded findings of exceptional precision and were deemed most useful by several authorities.

We are building on the infrastructure and methodological framework we have initiated for international linkage of vaccine safety data. Through this endeavour, we aim to provide public health decision makers with vaccine safety data of unprecedented accuracy and precision.

Vaccine safety information *when* it is most needed

Vaccines are distributed faster and to wider populations. Reliable safety information has to be available for decision makers to continue, modify or terminate these new programs. Ideally, this information should be available to them at a moment’s notice. As the number of available vaccines increases and the pace in which they are rolled out quickens, vaccine safety research must keep pace.

Making the need for timely research ever more crucial, today information on immunization campaigns is broadcast to most households by a 24 hour news cycle that knows no borders. Local safety concerns become global rapidly. When a concern arises, for each day that it is not thoroughly investigated, public trust erodes. This may cause more harm then the initial concern intended to prevent. It may even derail an entire immunization program causing untold suffering which could have been prevented if the research was there on time.

However, designing and agreeing upon rigorous research protocols takes time. Navigating large organizational bureaucratic channels to arrive at actionable research steps takes time. Conducting large studies well takes time. All activities in vaccine safety research take time the researcher does not have - if working alone.

Our collaboration is built for speed. One of our chief strengths is that even though we are the world's largest network of vaccine safety professionals, we have the ability to move fast. Our established research infrastructure, our dedicated focus to this single area, vaccine safety, our organizational structure and culture, our virtual research institute give us the ability to design and implement research projects quickly.

Designing protocols, methods, case definitions can take up to 50% of the time and resources in the design phase of research projects. Through standardization we are freeing the researcher from re-inventing the wheel at enormous cost. We employ pre-designed research protocols. The result is that when there is a call for research, much of the work preparing and even carrying out the research is already completed.

In the future, we plan to support ad hoc investigation by rapid response teams, to investigate concerns when it is needed the most.

Conclusion

In summary, immunization program decision makers, and in fact everybody concerned with the safety of vaccines, need accurate, precise and timely vaccine safety information. Our aim is to create the standards, methods, data sizes and research infrastructure needed for accurate, precise and actionable information. The result will be vaccines you can trust through better science.

You can read about our projects here. If you are a professional concerned with vaccine safety join us to create the world's leading vaccine safety resource; making safer vaccines through better science.